FDA Rare Disease Innovation Hub

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js-view-dom-id-88c5ce81fbd53f1d1aa9adc0ab5c8d2e52cb43f6cc09feb7f3e3249093996215"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/industry/fda-rare-disease-innovation-hub/fda-rare-disease-innovation-hub-qa" class="lcds-section-nav__link">FDA Rare Disease Innovation Hub Q&A</a></li> <li><a href="/industry/fda-rare-disease-innovation-hub/amy-comstock-rick-jd" class="lcds-section-nav__link">Amy Comstock Rick J.D.</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-c459a27ca7894a92c4fbfb0ee2191d4e58ef8e943c17ed0826bff9bfde02afd5"> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/industry">For Industry</a> </li> <li > <a href="/industry/medical-products-rare-diseases-and-conditions">Medical products for rare diseases and conditions</a> </li> <li > <a class="current-link">FDA Rare Disease Innovation Hub</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/industry/medical-products-rare-diseases-and-conditions" title="Medical products for rare diseases and conditions"> Medical products for rare diseases and conditions </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">FDA Rare Disease Innovation Hub</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Findustry%2Fmedical-products-rare-diseases-and-conditions%2Ffda-rare-disease-innovation-hub" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=FDA%20Rare%20Disease%20Innovation%20Hub&url=https://www.fda.gov%2Findustry%2Fmedical-products-rare-diseases-and-conditions%2Ffda-rare-disease-innovation-hub" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Findustry%2Fmedical-products-rare-diseases-and-conditions%2Ffda-rare-disease-innovation-hub&title=FDA%20Rare%20Disease%20Innovation%20Hub&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=FDA%20Rare%20Disease%20Innovation%20Hub&body=https://www.fda.gov%2Findustry%2Fmedical-products-rare-diseases-and-conditions%2Ffda-rare-disease-innovation-hub" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <figure> <div> <div class="field field--name-image field--type-image field--label-inline"> <div class="field--label">Image</div> <div class="field--item"> <picture> <source srcset="/files/styles/main_image_small/public/fda_rdih_v1_web-page_102924.jpg?itok=1opOrIII 1x" media="all and (max-width: 320px)" type="image/jpeg" width="320" height="180"/> <source srcset="/files/styles/main_image_medium/public/fda_rdih_v1_web-page_102924.jpg?itok=zM3O9eru 1x" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/fda_rdih_v1_web-page_102924.jpg?itok=zM3O9eru 1x" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/fda_rdih_v1_web-page_102924.jpg?itok=zM3O9eru 1x" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_1/public/fda_rdih_v1_web-page_102924.jpg?itok=Zy1iYcb2 1x" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" width="1020" height="574"/> <source srcset="/files/styles/main_image_1/public/fda_rdih_v1_web-page_102924.jpg?itok=Zy1iYcb2 1x" media="all and (min-width: 1201px)" type="image/jpeg" width="1020" height="574"/> <img loading="eager" src="/files/styles/main_image_medium/public/fda_rdih_v1_web-page_102924.jpg?itok=zM3O9eru" width="500" height="281" alt="FDA Rare Disease Innovation Hub" class="img-responsive" /> </picture> </div> </div> </div> </figure> <p></p><div class="callout"> <p>On January 15, 2025, the FDA Rare Disease Innovation Hub released its Strategic Agenda, which outlines the actions the Hub plans to undertake during its first year with extensive involvement from the rare disease community, while also addressing questions about the ultimate structure and programs of the Hub.  The Strategic Agenda reflects extensive input from and partnership with the larger rare disease community.</p><p class="text-align-center"><a href="/media/185144/download?attachment" data-entity-type="media" data-entity-uuid="4e2b99df-23a6-4f49-b4e2-44b664794a63" data-entity-substitution="media_download" title="Rare Disease Innovation Hub Strategic Agenda">Access the Strategic Agenda</a></p><p> </p></div> <p>Fundamental to the mission of the U.S. Food and Drug Administration is to <a href="/patients/learn-about-fda-patient-engagement" data-entity-type="node" data-entity-uuid="49032264-19d1-4a59-960b-d878e128ee8e" data-entity-substitution="canonical" title="Learn About FDA Patient Engagement">engage patients</a> and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease patients.</p><p>An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare diseases and conditions are life threatening, and most do not have approved treatments. </p><p>FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) with the goal of ultimately improving outcomes for patients.  Although the Hub will work across rare diseases, it will particularly focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood. </p><p>The Hub is co-led by the directors of Center for Biologics Evaluation and Research (CBER) and the FDA’s Center for Drug Evaluation and Research (CDER), in close collaboration with the FDA’s Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Orphan Products Development, and Office of Combination Products. </p><hr><h3 class="text-align-center">Connect with the Hub</h3><p class="text-align-center"><a href="mailto:RDInnovationHub@fda.hhs.gov">RDInnovationHub@fda.hhs.gov</a></p><hr><h3>Resources</h3><ul><li><a href="/vaccines-blood-biologics/cber-rare-disease-program" data-entity-type="node" data-entity-uuid="8f6f1c3a-9819-4751-8101-86166d65ce09" data-entity-substitution="canonical" title="CBER Rare Disease Program ">CBER Rare Disease Program</a></li><li><a href="/about-fda/center-drug-evaluation-and-research-cder/accelerating-rare-disease-cures-arc-program" data-entity-type="node" data-entity-uuid="3b6eb6bc-08da-4d67-bf14-a9e60e5a6aa2" data-entity-substitution="canonical" title="Accelerating Rare disease Cures (ARC) Program">CDER’s Accelerating Rare disease Cures (ARC) Program</a></li><li>FDA Voices: <a href="/news-events/fda-voices/fda-takes-exciting-steps-toward-establishing-rare-disease-innovation-hub" data-entity-type="node" data-entity-uuid="735df63e-90a0-40a5-b389-b078c825a823" data-entity-substitution="canonical" title="FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub">FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub</a></li><li>FDA Voices: <a href="/news-events/fda-voices/fda-rare-disease-innovation-hub-enhance-and-advance-outcomes-patients" data-entity-type="node" data-entity-uuid="938722b1-90cc-42ea-bb93-08c57efe8d39" data-entity-substitution="canonical" title="FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients">FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients</a></li><li>Public Meeting: <a href="/drugs/news-events-human-drugs/advancing-rare-disease-therapies-through-fda-rare-disease-innovation-hub-10162024" data-entity-type="node" data-entity-uuid="19c6c141-e0da-433f-89b9-26364d25a19e" data-entity-substitution="canonical" title="Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub - 10/16/2024">Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub</a><ul><li><a href="https://reaganudall.org/news-and-events/events/advancing-rare-disease-therapies-through-an-fda-rare-disease-innovation-hub">Key Meeting Themes</a></li></ul></li></ul><br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2025-01-15T00:00:00Z">01/15/2025</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Biologics</li> <li role="menuitem">Drugs</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/industry/medical-products-rare-diseases-and-conditions/fda-rare-disease-innovation-hub" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">FDA Rare Disease Innovation Hub</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-369da39efad44529af79e46dad81c7f140da35059baa273e5ebdb9fa44cb9d19"> 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